Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Not Applicable

Completed

• Conditions: Symptomatic Periapical Periodontitis
• Interventions: Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet; Drug: Oral placebo

• Registration Number: NCT03033147
• Lead Sponsor: Cairo University

Brief Summary

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

Detailed Description

Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.

Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).

Root canal treatment will then be carried out in a single visit.

Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-26
• Study Start: 2019-10-18
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
• Mandibular posterior teeth.
• Patients with non-contributory systemic condition.
• Patients who can understand pain scales and able to sign informed consent.

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Exclusion Criteria

• Patients allergic to penicillin.
• Patients who have a draining sinus tract.
• Retreatment cases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin/Clavulanate Potassium	Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet	Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment
Placebo	Oral placebo	placebo 30 minutes before root canal treatment

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Up to 7 days after endodontic treatment	Postoperative pain will be measured by a numerical rating scale (NRS).

Secondary Outcome Measures

Name	Time	Method
Swelling	Up to 7 days after endodontic treatment	The occurrence of Swelling will be measured by a questionnaire.

Trial Locations

Locations (1)

Cairo University Faculty of Dentistry; 🇪🇬 Cairo, Egypt